MALE FEMALE EXTENSION 3-WAY STOPCOCK PVC DEHP-FREE BPA-FREE 2.5X4.1MM MOBILE LUER LOCK VENT FILTER

  • Limited residual volume, internal tube diameter 2.5 mm
  • Pressure resistance: 2 bar
  • Mobile male Luer Lock
  • Tritan BPA-free 3-way stopcock

Description

The INFINEED "precision plus" 3-way DEHP free, BPA free PVC extension has been designed to minimise its environmental impact, using only raw materials that are free from endocrine disruptors (elimination of components, including DEHP or BPA). The extension has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bar.

BPA-free 3-way stopcock: Lipid-resistant (96 hours to 7 days) with large valve stopcock and arrows indicating the direction of flow, permanently attached to the extension tube.

Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 2.5 x 4.1mm

End cap: Mobile Luer Lock

End stopper: 0.8 µm purge filter with hydrophobic membrane

Resistance to pressure of 2 bar according to the claim of compliance with reference standard NF EN ISO 8536 -9, 10 bar according to tests performed by Didactic (see scientific and technical file: Lipid-resistant from 96 hours to 7 days)

Lipid resistant from 96 hours to 7 days 

Technical
information

Indications 
This medical device is intended for the parenteral administration of injectable preparations (drugs, nutrition).

Used materials 
PVC DINCH (DEHP<0.1%(m/>)): Tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve, purge filter - Tritan® BPA-free: Stopcock body - Acrylonitrile butadiene styrene: Mobile male Luer Lock, fixed female Luer lock

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

  • MD class : IIa
  • MD notified body : 0123
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : V

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices;
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment
  • Infusion equipment for medical use — Part 9: Fluid lines for single use with pressure infusion equipment

economic operator 

  • MANUFACTURER : DIDACTIC / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

The INFINEED "precision plus" 3-way DEHP free, BPA free PVC extension has been designed to minimise its environmental impact, using only raw materials that are free from endocrine disruptors (elimination of components, including DEHP or BPA). The extension has been tested at pressures well above those recommended for gravity infusion; laboratory tests have shown a pressure resistance of approximately 10 bar.

BPA-free 3-way stopcock: Lipid-resistant (96 hours to 7 days) with large valve stopcock and arrows indicating the direction of flow, permanently attached to the extension tube.

Tubing: PVC (DINCH) designed for comfort, optimal flow adjustment consistency and to prevent kinks. Diameter: 2.5 x 4.1mm

End cap: Mobile Luer Lock

End stopper: 0.8 µm purge filter with hydrophobic membrane

Resistance to pressure of 2 bar according to the claim of compliance with reference standard NF EN ISO 8536 -9, 10 bar according to tests performed by Didactic (see scientific and technical file: Lipid-resistant from 96 hours to 7 days)

Lipid resistant from 96 hours to 7 days 

Indications 
This medical device is intended for the parenteral administration of injectable preparations (drugs, nutrition).

Used materials 
PVC DINCH (DEHP<0.1%(m/>)): Tubing - Polypropylene: Protective cap, stopcock stopper - Polyethylene: Stopcock valve, purge filter - Tritan® BPA-free: Stopcock body - Acrylonitrile butadiene styrene: Mobile male Luer Lock, fixed female Luer lock

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

  • MD class : IIa
  • MD notified body : 0123
  • EU directive/regulation : 93/42/CEE - 2007/47/CEE
  • annexe : V

sterile 

  • sterile : yes
  • sterilization method : ethylene oxide

conformity 

  • Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
  • Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices;
  • Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment
  • Infusion equipment for medical use — Part 9: Fluid lines for single use with pressure infusion equipment

economic operator 

  • MANUFACTURER : DIDACTIC / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

Associated products

MALE FEMALE EXTENSION 3 WAY STOPCOCK PVC DEHP-FREE BPA-FREE 2.5X4.1MM FIXED LUER LOCK
MALE FEMALE EXTENSION 3-WAY STOPCOCK PVC DEHP-FREE BPA-FREE 2.5X4.1MM MOBILE LUER LOCK VENT FILTER 100 CM

Associated products

MALE FEMALE EXTENSION 3 WAY STOPCOCK PVC DEHP-FREE BPA-FREE 2.5X4.1MM FIXED LUER LOCK
MALE FEMALE EXTENSION 3-WAY STOPCOCK PVC DEHP-FREE BPA-FREE 2.5X4.1MM MOBILE LUER LOCK VENT FILTER 100 CM

Request for technical documentation

  • Didactic formally undertakes not to sell, rent or exchange any personal information. In application of articles 39 and following of the law of January 6, 1978 modified relating to data processing and freedoms (CNIL), you have the right to access, delete and rectify information concerning related to you.